FDA.reportPublic FDA data

Topiramate

Product NDC
0480-2358
11-digit product format
004802358
Labeler code
0480
Product ID
0480-2358_38168585-df97-4809-8f00-a61122c7259f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA206210
Marketing category
ANDA
Marketing start
2023-05-03
Substance
TOPIRAMATE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1436239, 1437278, 1437283, 1437288

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-2358-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007
0480-2358-56Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-2358TOPIRAMATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20250510_4f20155f-05b9-40ec-af34-3b58aa8d60d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSN4f20155f-05b9-40ec-af34-3b58aa8d60d47
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSN4f20155f-05b9-40ec-af34-3b58aa8d60d47
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSN4f20155f-05b9-40ec-af34-3b58aa8d60d47
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSN4f20155f-05b9-40ec-af34-3b58aa8d60d47
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCD4f20155f-05b9-40ec-af34-3b58aa8d60d47
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCD4f20155f-05b9-40ec-af34-3b58aa8d60d47
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCD4f20155f-05b9-40ec-af34-3b58aa8d60d47
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCD4f20155f-05b9-40ec-af34-3b58aa8d60d47
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSY4f20155f-05b9-40ec-af34-3b58aa8d60d47
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSY4f20155f-05b9-40ec-af34-3b58aa8d60d47
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSY4f20155f-05b9-40ec-af34-3b58aa8d60d47
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSY4f20155f-05b9-40ec-af34-3b58aa8d60d47
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSN25b377f7-ea89-fb56-e063-6394a90a239d2
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCD25b377f7-ea89-fb56-e063-6394a90a239d2
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSY25b377f7-ea89-fb56-e063-6394a90a239d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-2358-0100480235801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-01) 2023-05-03NoNoCurrent
0480-2358-560048023585630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2358-56) 2023-05-03NoNoCurrent
0480-2358-99004802358997400 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0480-2358-99)10-MAR-23Current